Question

During execution of a medical device project, the project manager learns that a subcomponent supplied by an approved vendor no longer meets the regulatory documentation requirements because the vendor changed its manufacturing process. The component has already been integrated into three prototype units scheduled for regulatory submission next month. What should the project manager do FIRST?

Accepted Answer

Assess the impact of the non-compliance on the project's compliance obligations and affected deliverables before deciding on a response

Answer

Immediately replace the vendor with one whose process already satisfies the documentation requirements

Answer

Proceed with the regulatory submission on schedule and disclose the process change if the regulator raises a question

Answer

Escalate to the sponsor and request additional budget to redesign the affected prototype units